HYPERACCELERATED AWARD/MECHANISMS IN IMMUNOMODULATION TRIALS
Release Date: October 24, 2000
RFA: AI-01-001
National Institute of Allergy and Infectious Diseases
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Neurological Disorders and Stroke
Letter of Intent Receipt Date: One month prior to application receipt date.
Application Receipt Date: Applications will be accepted MONTHLY on the 9th of
each month.
THIS RFA USES "MODULAR GRANT" CONCEPTS AND JUST IN TIME. THIS RFA
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS
THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS
RFA.
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID), the
National Institute on Aging (NIA), the National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS), the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National
Institute of Neurological Disorders and Stroke (NINDS) of the National
Institutes of Health (NIH) invite investigator-initiated research
applications for mechanistic studies in clinical trials of
immunomodulatory interventions for immune system mediated diseases,
including, but not limited to, asthma and allergy, graft failure in
solid organ, tissue, cell and stem cell transplantation, and autoimmune
diseases. Specifically, this Request for Applications (RFA) is a
continuation and modification of RFA AI-00-005. It focuses on the
inclusion of patients and utilization of patient samples for the
evaluation of immunologic and other relevant parameters to facilitate
the study and definition of immunological mechanisms underlying the
intervention, the mechanisms of disease pathogenesis,
surrogate/biomarkers markers of disease activity and therapeutic
effect, and mechanisms of human immunologic function. The parent or
core clinical trial must have independent financial support and will
NOT receive support under this RFA. Proposed mechanistic studies
associated with clinical trials supported by industry are particularly
encouraged but clinical trials supported by any source, public or
private, are eligible.
In order to review and confer awards to applications received in
response to this RFA in a timely fashion without delay of the parent or
core clinical trial, NIAID has developed a pilot project in
collaboration with the Center for Scientific Review (CSR): NIAID/CSR
PILOT OF HYPERACCELERATED REVIEW/AWARD. All applications responding to
this RFA will be subject to this hyperaccelerated review/award process.
Highly meritorious applications selected for funding under this RFA
will receive their awards thirteen weeks after the application receipt
date. Holidays and other circumstances may alter this schedule
slightly.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS led national activity for setting priority areas. This Request for
Applications (RFA), Title of RFA, is related to one or more of the
focus areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign for-profit and
non-profit organizations; public and private institutions, such as
universities, colleges, hospitals, laboratories, units of State and
local governments; and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
MECHANISM OF SUPPORT
The mechanism of support will be the individual research project grant
(R01). The total requested project period for an application submitted
in response to this RFA may not exceed four years. Some sponsoring
Institutes may administratively limit the duration of award.
Applicants for the R01 mechanism must not exceed a first-year limit of
$250,000 direct costs. Modular grant procedures should be used.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.
Specific application instructions have been modified to reflect
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined
by the NIH. Complete and detailed instructions and information on
Modular Grant applications can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm.
A notice of modification and update (OD-00-046) regarding modular
grants was released on 7/24/00 and can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html.
FUNDS AVAILABLE
The estimated total funds, direct and facilities and administrative
(F&A), available for the first year of support for all awards made
under this RFA in FY 2001 will be $1,850,000. The usual NIH policies
governing grants administration and management will apply.
Although this program is provided for in the financial plans of the
participating institutes, awards pursuant to this RFA are contingent
upon the availability of funds for this purpose and the receipt of a
sufficient number of applications of high scientific merit. Funding
beyond the first and subsequent years of the grant will be contingent
upon satisfactory progress during the preceding years and availability
of funds.
RESEARCH OBJECTIVES
Background
In December 1996, NIAID convened a workshop at which leading basic and
clinical immunologists discussed the role the NIH should play in
current and projected clinical trials for various immune mediated
diseases. It was considered likely that clinical trials of many new
immunologic interventions would be supported by the
pharmaceutical/biotechnology industry. However, gaps in both knowledge
and in research effort were identified which represent opportunities
for the NIH to contribute to progress in this area.
There was agreement that the mechanisms underlying immunologic
interventions are poorly understood even in cases where efficacy has
been shown (e.g., allergen immunotherapy and IFN Beta treatment for
multiple sclerosis.) In addition, clinical trials supported by
industry and other sources including NIH often do not include studies
of underlying mechanisms. There was consensus that high priority
should be given to the utilization of patient samples from clinical
trials in immunologic diseases for studies of the basic underlying
mechanisms of therapeutic effect, immunologic function, and disease
pathogenesis.
There was also agreement that the usual time required for grant review
and funding is often incompatible with the time line of a clinical
trial. Specifically, when a clinical protocol is finalized (which is
required for applications submitted under this RFA), investigators are
often ready to begin as soon as Institutional Review Board approval is
obtained. NIAID was encouraged to develop a means of responding
rapidly to opportunities to study underlying mechanisms in order to
facilitate collaborations with industry-supported clinical trials.
These recommendations were strongly supported by a large number of
investigators who participated in NIAID focus groups in the
winter/spring of 1997. The RFA AI-98-006 and the NIAID/CSR PILOT OF
HYPERACCELERATED REVIEW/AWARD were developed in order to implement
these recommendations and exploit the research opportunities
identified. Based on the successful implementation of RFA AI-98-006,
the follow-up RFA AI-00-005 and the Pilot, the current RFA is being
issued to continue this effort.
Research Objectives and Scope
The objective of this RFA is to support mechanistic research studies in
clinical trials of immuno-modulatory interventions for immune system
mediated diseases, including asthma and allergy, graft failure in solid
organ and stem cell transplantation, and autoimmune diseases.
Specifically, the goal is to utilize patients and patient materials
from such trials for the evaluation of immunologic and other relevant
parameters in order to study the underlying mechanisms of the
intervention, the mechanisms of disease pathogenesis, surrogate markers
of disease activity and therapeutic effect, and mechanisms of human
immunologic function. Such studies are not part of the parent or core
clinical trial, and are commonly referred to as substudies or ancillary
studies. The parent or core clinical trial must have independent
financial support and will NOT receive support under this RFA. Clinical
trials supported by any source, public or private, are eligible.
Clinical trials of any phase (i.e. I-IV) are eligible. Examples of
relevant research include, but are not limited to, the following:
o Quantitation of disease-related, autoreactive or alloreactive
lymphocytes using methods such as MHC/peptide tetramers, chimeric
antibodies, or very early activation antigens.
o Analysis of autoreactive or alloreactive cells by PCR for expression
of genes implicated in immunity or inflammation, or by FACS for cell
surface markers that identify functions (e.g., cytokine receptors that
distinguish TH1 from TH2 or chemokine receptors or integrins that
indicate preferential
patterns of homing).
o Assessment of reagents that can identify newly recognized
populations of regulatory T cells (e.g., Valpha24JalphaQ bearing
invariant T cells) which appear to be altered in autoimmune disease.
o Identification and evaluation of cytokine and cytokine receptor
polymorphisms and analysis for genetic linkage to disease.
o Use of high throughput technologies (e.g. chip technology using
expressed sequence tags) to identify and evaluate genes activated in
disease sites.
o Identification of useful surrogate markers by correlation of the
above parameters with disease activity and/or response to intervention.
o Comparison of samples from peripheral blood with those from sites of
disease, i.e., do peripheral blood samples provide useful information?
o Assessment for the presence of molecular evidence (e.g. using PCR
probes) of potential causative environmental agents.
The areas outlined above are not intended to be all-inclusive.
NOTE: Clinical trials in infectious diseases, which involve the immune
system (e.g. AIDS and Lyme Disease), are NOT eligible for this RFA.
SPECIAL REQUIREMENTS
To assist in the overall evaluation of this Pilot RFA, the Principal
Investigators of grants funded under this RFA will be asked to provide
brief (1-2 pages) summary report one year following the end of the
funding period. The reports will summarize the major scientific
knowledge gained and identify other substantive outcomes such as
publications, patents, and new grants, contracts, or research studies
based on this mechanistic research.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups
and their sub-populations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons
not to include them. This policy applies to all initial (Type 1)
applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects" that was published
in the NIH Guide for Grants and Contracts, March 6, 1998, and is
available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may obtain copies of these policies from these sources or
from the program staff (listed in INQUIRIES below) who may also provide
additional relevant information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained
within specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no
obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit, one month prior to the
application receipt date, a letter of intent that includes: a
descriptive title of the overall proposed research; the name, address
and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions and the number and
title of this RFA. Although the letter of intent is not binding and
does not enter into the review of a subsequent application, the
information that it contains allows NIH staff review to estimate the
potential review workload and to plan the review. The Letter of Intent
is to be sent to Dr. Politis at the address listed under INQUIRIES.
APPLICATION PROCEDURES
Applicants are strongly encouraged to contact program staff listed
under INQUIRES with any questions regarding the responsiveness of their
proposed project to the goals of this RFA.
Applications are to be submitted on the grant application for PHS 398
(rev. 4/98). These forms are available at most institutional offices
of sponsored research; from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email: grantsinfo@nih.gov; and on the Internet at
https://grants.nih.gov/grants/funding/phs398/phs398.html
For purposes of identification and processing, item 2a on the face page
of the application must be marked "YES" and the RFA number “AI-01-001”
and the words "HYPERACCELERATED AWARD/MECHANISMS IN IMMUNOMODULATORY
TRIALS" must be entered on the face page.
Applications must be received by the 9th of each month. Applications,
which are received after the 9th, will automatically be processed the
following month. Applications not received as a single package (See
Special Instructions Section below) on the receipt date or not
conforming to the instructions contained in PHS 398 (rev. 4/98)
Application Kit (as modified in, and superseded by, the special
instructions below, for the purposes of this RFA), will be judged non-
responsive and will be returned to the applicant.
The RFA label available in the application form PHS 398 must be affixed
to the bottom of the face page. The RFA label and line 2 of the
application must indicate the RFA number. Failure to use this label
could result in delayed processing of the application such that it may
not reach the review committee in time for review. The sample RFA label
available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been
modified to allow for this change. Please note this is in pdf format.
If the application submitted in response to this RFA is substantially
similar to a grant application already submitted to the NIH for review,
but that has not yet been reviewed, the applicant will be asked to
withdraw either the pending application or the new one. Simultaneous
submission of identical applications will not be allowed, nor will
essentially identical applications be reviewed by different review
committees. Therefore, an application that is essentially identical to
one that has already been reviewed cannot be submitted in response to
this RFA. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an introduction addressing the previous critique.
Submit a signed, typewritten original of the application, including the
checklist; five signed, exact, single-sided photocopies; and five sets
of appendix material in one package to:
PLEASE NOTE THAT THIS ADDRESSES IS DIFFERENT FROM THE INSTRUCTIONS IN
THE PHS 398 APPLICATION KIT AND FAILURE TO COMPLY WILL RESULT IN
DEFERRAL OF REVIEW.
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 2030, MSC 7720
BETHESDA, MD 20892-7720
BETHESDA, MD 20817 (for express/courier service)
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research. If so, a letter of agreement from either the GCRC Program
Director or Principal Investigator should be included with the
application.
SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA
The research plan in the application should be limited to 15 pages.
The research plan includes specific aims, background and significance,
preliminary studies, and research design and methods (Sections A to D).
In the research plan, include a justification for why the proposed
studies require the use of patients in this clinical trial as opposed
to using patients with the same disease state but not in a trial.
Methods of data analysis and power calculations must be included.
Include a justification for the required sample size. A restatement of
the sample size calculations from the parent clinical trial is
insufficient. If appropriate to your application, discuss whether it
is necessary to perform the mechanistic studies on all patients
enrolled in the parent trial or whether a sub-sample would be
sufficient. There must be a discussion of the statistical procedures
that will be used to analyze the data. The manner in which
immunological parameters will be related to the clinical outcomes in
the main study should also be discussed.
The protocol and the investigators’ brochure for the parent or core
clinical trial should be included with the application as part of the
human subjects’ section. Inclusion of the complete clinical protocol
within the PHS 398 grant application is intended to simplify the
application process by eliminating the need to duplicate protocol
details in the Research Plan section. Informed Consent form(s) must
also be included as part of this section. While drafts of the consent
forms at participating sites are not required, it would be useful to
include them if they are available. NIH will treat as confidential any
scientific, preclinical, clinical, or formulation data and information
that the sponsor deems to be proprietary and confidential.
Amended applications will be accepted for Hyperaccelerated Review/Award
ONLY if invited by NIH. Applicants with minor or easily corrected
problems will be invited to submit an abbreviated amendment (5 page
limit and one time only), which directly addresses the questions and
concerns raised in the initial review.
In order to ensure coordination between the mechanistic studies and the
parent or core clinical trial, the principal investigator and the
sponsor of the parent or core clinical trial must provide written
agreement for the conduct of the mechanistic studies as presented in
the application.
Prior to award, the applicant must provide to the funding institute a
memorandum of understanding signed by the applicant, an appropriate
representative of the applicant institution, the principal investigator
of the parent or core clinical trial, and an appropriate representative
of the sponsor of the parent or core clinical trial. This memorandum
will indicate agreement and will outline the specifics of the agreement
for the following areas: 1) data from the mechanistic studies
(including ownership, analysis, access, and release), 2) access to the
data from the parent or core clinical trial (how/when) which is needed
to analyze the mechanistic studies, including procedures for prevention
of unblinding of the parent trial, 3) documentation of quality
assurance procedures for both the parent trial and the mechanistic
studies, and documentation of Data Safety Monitoring procedures for the
parent trial, especially for efficacy trials, 4) ownership of
intellectual property developed during the mechanistic studies, and 5)
publication of the results of the mechanistic studies.
MODULAR APPLICATION DETAILS:
The modular grant concept establishes specific modules in which direct
costs may be requested as well as a maximum level for requested
budgets. Only limited budgetary information is required under this
approach. The just-in-time concept allows applicants to submit certain
information only when there is a possibility for an award. It is
anticipated that these changes will reduce the administrative burden
for the applicants, reviewers and Institute staff. The research grant
application form PHS 398 (rev. 4/98) is to be used in applying for
these grants, with the modifications noted below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000
modules, up to a total direct cost request of $250,000 per year. The
total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398
application instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct
Costs (in $25,000 increments up to a maximum of $250,000) and Total
Costs [Modular Total Direct plus Facilities and Administrative (F&A)
costs] for the initial budget period Items 8a and 8b should be
completed indicating the Direct and Total Costs for the entire proposed
period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form
Page 4 of the PHS 398. It is not required and will not be accepted with
the application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete
the categorical budget table on Form Page 5 of the PHS 398. It is not
required and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget
Narrative page. (See
https://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form page.
o Under Personnel, list all project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the
NIH appropriation language salary cap and the NIH policy for graduate
student compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs
(direct plus facilities and administrative) for each year, each rounded
to the nearest $1,000. List the individuals/organizations with whom
consortium or contractual arrangements have been made, the percent
effort of key personnel, and the role on the project. Indicate whether
the collaborating institution is foreign or domestic. The total cost
for a consortium/contractual arrangement is included in the overall
requested modular direct cost amount. Include the Letter of Intent to
establish a consortium.
Provide an additional narrative budget justification for any variation
in the number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information
used by reviewers in the assessment of each individual's qualifications
for a specific role in the proposed project, as well as to evaluate the
overall qualifications of the research team. A biographical sketch is
required for all key personnel, following the instructions below. No
more than three pages may be used for each person. A sample
biographical sketch may be viewed at:
https://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate
the type of agreement and the date. All appropriate exclusions must be
applied in the calculation of the F&A costs for the initial budget
period and all future budget years.
o The applicant should provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review.
REVIEW CONSIDERATIONS
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by a Scientific Review
Group (SRG) established for the NIAID/CSR PILOT OF HYPERACCELERATED
REVIEW/AWARD and convened in accordance with NIH peer review
procedures. As part of the initial merit review, all applications will
receive a written critique, will be discussed by the SRG, assigned a
priority score, and receive a second level review by the National
Advisory Council of the assigned Institutes.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
The reviewers will comment on the following aspects of the application
in their written critiques in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of
these goals. Each of these criteria will be addressed and considered
by the reviewers in assigning the overall score weighting them as
appropriate for each application. Note that the application does not
need to be strong in all categories to be judged likely to have a major
scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
1. Significance. Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
2. Approach. Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
3. Innovation. Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
4. Investigator. Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
5. Environment. Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
The initial review group will also examine: the appropriateness of
proposed project budget and duration; the adequacy of plans to include
both genders, minorities and their subgroups, and children as
appropriate for the scientific goals of the research and plans for the
recruitment and retention of subjects; adequacy of plans for including
children as appropriate for the scientific goals of the research; the
provisions for the protection of human and animal subjects; and the
safety of the research environment.
AWARD CRITERIA
Funding decisions will be made on the basis of scientific and technical
merit as determined by peer review, program balance, and the
availability of funds.
INQUIRIES
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.
Direct inquiries regarding programmatic (research scope and
eligibility) issues to:
Stephen M. Rose, Ph.D.
Chief, Genetics and Transplantation Branch
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
NIH
6700-B Rockledge Drive, Room 5130
Bethesda, MD 20892-7640
301.496.5598 voice
301.402.2571 fax
SRose@niaid.nih.gov
Anna M. McCormick, Ph.D.
Chief, Genetics and Cell Biology Branch
Genetics Program Director
Biology of Aging Program
National Institute on Aging
Gateway Building, Suite 2C231
Bethesda, Maryland 20892 (20814 for express deliveries)
Phone: 301-496-6402
FAX: 301-402-0010
mccormia@exmur.nia.nih.gov (or am38k@nih.gov)
Susana A. Serrate-Sztein, M.D.
Rheumatic Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-25E, MSC 6500
Bethesda, MD 20892-6500
Telephone: (301) 594-5032
FAX: (301) 480-4543
Email: szteins@exchange.nih.gov
Joan T. Harmon, Ph.D.
Diabetes Research Section
National Institute of Diabetes and Digestive and Kidney Disease
45 Center Drive, Room 5AN-18G, MSC 6600
Bethesda, MD 20892-6600
Telephone: (301) 594-8808
FAX: (301) 480-3503
Email: jh90u@nih.gov
A. P. Kerza-Kwiatecki, Ph.D.
Program Officer, DCIID
National Institute of Neurological Disorders and Stroke
Federal Building, Room 504
7550 Wisconsin Avenue
Bethesda, MD 20892
Telephone: 301-496-1431
FAX: 301-402-2060
E-Mail: ak45w@nih.gov
Direct inquiries regarding review issues and special instructions for
application preparation to:
Alexander D. Politis, Ph.D.
Scientific Review Administrator
Special Study Section SSS-J
Center for Scientific Review, NIH
Room 4204, RKLII Building, MSC 7812
6701 Rockledge Drive
Bethesda, MD 20892-7812 (20817 for couriers)
Telephone: 301-435-1225
FAX: 301-480-4042
E-Mail: politisa@csr.nih.gov
Direct inquiries regarding fiscal matters to:
Sharie Bernard
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B21
6003 Executive Boulevard
Bethesda, MD 20892-7610
Telephone: 301-402-5540
FAX: 301-480-3780
E-mail: sb34k@nih.gov
Schedule
Letter of Intent Receipt Date: One month prior to application receipt date.
Application Receipt Date: 9th of each month.
Earliest Award Date: 13 weeks after receipt of application.
AUTHORITY AND REGULATIONS
This program is supported under authorization of the Public Health
Service Act, Sec. 301 (c), Public Law 78-410, as amended. The
Catalogue of Federal Domestic Assistance Citations are No. 93.855 -
Immunology, Allergy, and Transplantation Research, No. 93.853, No.
93.838, No. 93.846 –Aging, No.93.866 - Arthritis, Musculoskeletal and
Skin Diseases Research, and No. 93.847 - Diabetes, Endocrinology and
Metabolism Research. Awards will be administered under PHS grants
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems review.
The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, and
portion of a facility) in which regular or routine education, library,
day care, health care or early childhood development services are
provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.